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iso 13485 internal auditor course online

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As a medical device manufacturer, even if you not have the ISO 13485 certification, you have to comply with the applicable regulatory requirements to market your products. – PowerPoint PPT presentation

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Title: iso 13485 internal auditor course online


1
The uses of ISO 13485 Certification for medical
devices? As a medical device
manufacturer, even if you not have
the ISO 13485 certification, you have
to comply with the applicable
regulatory requirements to market your
products. Compliance with regulatory
Classes requirements is given equal
importance in ISO 13485, with the latest
version putting additional emphasis on this
factor. The Food and Drug Administration
(FDA) is a federal agency of the United
States of America responsible for
safeguarding and maintaining public health
through the regulation and supervision of medical
devices and other products. The Center for
Devices and Radiological Health (CDRH) is the
authority for regulating and approving
medical devices under the domain of the FDA. In
1976, the Federal Food, Drug and Cosmetic Act
were revised. The ISO 13485 Certification
Provider for Medical Device section was
also amended, instituting three regulatory
classes for medical devices. The three
classes are based on the extent of control
required to guarantee that the devices are safe
to use and effective for their intended
functions. Regulatory classes for medical
devices to ISO 13485 Certification The
classification procedure and market approval
processes are fully explained in the 21 CFR
Part 860 (Code of Federal Regulations
for Medical Device Classification
Procedures). The FDA, in the United States,
permits devices to access the market through
two regulated paths. The easiest and most widely
used is the 510(k) process (which is titled after
the CFR section). When a supplier can prove that
its newly Introduced device is Similar to a
former officially supplied medical device, it can
access the market with the permission of the FDA
as the defined controls required in this
process are met. The 510(k) process doesnt
involve the high level of testing that clinical
trials require. The other path to the
marketplace is the Premarket Approval (PMA)
process, which requires approval by the FDA.
Following are the classes of medical
devices Class I Devices placed into Class I
offer the least potential for harm to the user
and/or the patient. These devices commonly
have a simpler design than those
2
devices that fall into the other two
classes. Class I devices are not designed
to assist or support life and, as such, are
unlikely to pose any significant risk of illness
or injury. Hand-held surgical instruments,
elastic bandages, mercury thermometers, and
examination gloves are some examples of Class I
devices. Within Class I, if a device is
classified into a general category of
exempted devices, then no Premarket
Notification application or FDA clearance is
needed before selling the device in the U.S.
But, the supplier is mandatory to register its
organization and submit a list of generic
products to the FDA. So, Class I devices are
under the fewest regulatory controls. Class
I devices that are not listed as exempted
devices undergo a Pre-market Notification app
with the FDA. This Pre- market Notification app
is also applicable for Class II devices. Class
II Class II devices are more sensitive in terms
of life support than those in Class I. Devices
in Class II are controlled with a higher
level of assurance than Class I devices,
and are regulated by the FDA to ensure
that they perform their intended functions well
without resulting in any injury or damage to the
patient or user. Such eg, of Class II
devices are infusion pumps, acupuncture
needles, air purifiers, powered wheelchairs,
pregnancy test kits, and surgical drapes. The
Food, Drug and Cosmetic Act under Section
510(k) mandates that medical device suppliers
who want to sell their devices in the Class II
category must submit registration showing their
intent to market a device. ISO 13485
Certification in Quality Management System is
the process of application submission known as
the Premarket Notification (PMN), and is also
referred to as 510(k). Under this section the
supplier has to convince the FDA that the new
device is as safe and effective as one of the
devices already marketed with FDA approval. If
FDA recognizes the application of that
device as substantially equivalent to a
device already on the market, the supplier can
then market that approved device. You can also
search for devices in the FDAs 510(k)
Pre-market Notification searchable database to
confirm that the device is already approved for
the market,
or was on the market before 1976.
3
Class III Class III devices are the most
critical devices, designed to assist or
support life. These devices include
implants, and carry a high risk of injury
or illness. Examples of Class III devices
include implantable pacemakers, HIV diagnostic
tests, pulse generators, automated external
defibrillators, and breast implants. Class III
devices are routed through Premarket Approval
(PMA). PMA is the more effective control of the
FDA. Any new medical devices based on new
materials or containing a different design from
what was previously marketed, are mandated to
submit a Premarket Approval application. The
application for approval must show justification
gathered from clinical trials on humans proving
that the medical products are safe to use
and perform their intended functions. You can
also search for devices in the development phase
in the FDAs Premarket Approval searchable
database to confirm that your device is critical
for human life. Significance of classes -
medical device manufacturers and suppliers ISO
13485 Certification for Medical Device
helps you to build a Quality Management
System with the necessary considerations for the
(above-mentioned) regulatory requirements. FDAs
CDRH, has three different medical device classes,
and keeps strict control over the medical
device market in the United States. Devices
that are the least harmful (e.g., elastic
bandages, mercury thermometers) do not require
protocols to validate their safety and
effectiveness. In the Classes Devices whos
designs are already established as fit for
purpose and safe for use undergo a simple
notification process that usually does not
require clinical trials, just an expression of
equivalence with a previously approved and
marketed device. Devices that are critical for
life are categorized in Class III and undergo a
detailed process of approval under which
clinical trials are done. The results of
clinical trials are kept confidential. Thus, the
FDA has reduced the possibility of defective and
life-threatening devices coming to market. It is
important for the well-being of the people that
devices are regulated. State authorities
can make control over
devices effectively by this way. Visit iso
13485 internal auditor course online
4
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